A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer

Inclusion criteria

• ✓. Male or female subjects aged 18-75 years (including 18 and 75 years);
• ✓. Stage IV NSCLC or Stage IIIB and IIIC NSCLC that cannot be treated with radical radiotherapy(IASLC); Dose escalation: ALK rearrangement or ROS1 rearrangement positive, the test specimen and method is not limited;Patients were required to have experienced treatment failure or disease progression after prior ALK inhibitor therapy or were unable to afford ALK inhibitors, regardless of other previous anti-tumor therapies.
• ✓. Dose escalation: ECOG score 0-1; Dose expansion: ECOG score 0-2;
• ✓. Dose expansion: Subjects must have at least one measurable target lesion as defined by RECIST V1.1 and the lesion has not previously been treated with radiation or has had significant disease progression after radiation therapy;
• ✓. All acute toxicities from prior anti-cancer treatment or complications/sequelae from surgical procedures are resolved to baseline or ≤ grade 1 (CTCAE V5.0, hair loss or other toxicities deemed by the investigator to pose no safety risk to the subject);
• ✓. All previous antitumor therapies (including chemotherapy, radiotherapy and immunotherapy) have been stopped for at least 4 weeks before the first administration of XZP-3621 (in which nitrosoreas or mitomycin should be stopped for≥ 6 weeks, and oral small molecule targeted therapy drugs and Chinese medicine (including decoction or Chinese patent medicine) should be stopped for at least 2 weeks);Palliative radiation therapy (irradiation of non-target lesions, local administration of non-target lesions) for the purpose of relieving local symptoms was allowed to be completed one week before study enrollment;
• ✓. The expected survival was determined by the investigator to be 12 weeks or more;
• ✓. At the time of enrollment, the subject's organ function at baseline was good, and the laboratory data met the following criteria: